Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Testing Methods
: 11 Apr 2019 - 12 Apr 2019
: Bethesda, United States
The control of microorganisms in our manufacturing processes and environments is one of the most important tasks in ensuring products are safe and effective. This is true for conventional pharmaceuticals, biotech products, compounding pharmacy drugs, gene and cell therapy products and radiopharmaceuticals. However, conventional microbiology methods are antiquated and do not support the need for faster, accurate and reproducible results. Therefore, the modern laboratory should develop innovative approaches for the detection, quantification and identification of microorganisms using alternative and rapid microbiological methods (RMM).
This comprehensive training course is designed to provide an intensive review of currently available RMM technologies, validation strategies, applications for use, global regulatory views and validation expectations, financial justification models, and technology identification and implementation plans.
The most recent guidance documents on how to validate RMMs, including PDA Technical Report No. 33, USP chapter 1223 and Ph. Eur. chapter 5.1.6 will be discussed in great detail. Additionally, strategies on how to use statistical methods when comparing a new RMM with the compendia method will also be presented, as this is now a regulatory expectation when a firm is seeking approval to use the new method. Case studies on meeting validation and equivalency criteria will also be presented.
Taught by one of the industry’s global leaders in rapid methods, delegates will be immersed in discussions that will provide a meaningful and understandable roadmap for how to evaluate RMMs and employ them in their own laboratory and manufacturing areas.